MalfunctionCIT
CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Feb 23, 2007
Report 2018433-2007-00007 · MDR key 953198
Device
Generic name
Quantitation Of Aspartate Aminotransferase
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
8D37-30
Lot number
46059HWH00
Product problems
- Mislabeled
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED THAT THEY RECEIVED THREE PACKS OF THE ASPARTATE AMINOTRANSFERASE ACTIVATED (AST-A) REAGENTS AND NOTICED THAT THE BARCODE AROUND THE CARTRIDGE IS LABELED AST-A AND SCANS AS AST-A BUT THE LABEL ON THE TOP OF THE REAGENT IS LABELED ALT-A. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.